510(k) K223078 · CIG Diazo Colorimetry, Bilirubin
Atellica® CH Diazo Direct Bilirubin (D_DBil)
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jun 12, 2023 |
| Received | Sep 30, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223078
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.